Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Physical activity variables of upper limbs movement at home
研究概览
简要总结
Validation of a measure specifically suitable to evaluate the residual function of upper limbs of non-ambulant neuromuscular patients, especially with Duchenne muscular dystrophy and spinal muscular atrophy.
This approach is of fundamental importance for clinical monitoring and preparing the future therapeutic trials.
详细描述
The main objective is the continuous measurement of muscle activity in a standardized setting and in the non ambulatory patient's natural environment. This measure uses an innovative technology based on accelerometer and magneto-inertial sensors. The system is intended to measure the physical activity of patients from the extraction of data recorded by the sensors in the three space axes.
The non ambulatory patients will be included and evaluated at baseline and 14 days later. The patients wear the accelerometer device during some standard evaluations and also at home continuously for 14 days.
With this protocol the investigators want to try to find the best variable that characterizes the movement of the upper limbs of non-ambulant neuromuscular patients.
The aim of Pre-Acti is to propose a primary outcome measure that may be used in clinical monitoring of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 10 years
- •neuromuscular disease documented by genetic testing or by muscle biopsy
- •not able to walk 10 meters without support
- •capable of sitting upright in a wheelchair for at least 3 hours
- •subject affiliated to a social security system
- •subject who signed an informed consent
排除标准
- •severe intellectual impairment limiting the comprehension of the demanded tasks
- •acute neurologic, inflammatory, infectious, endocrine, orthopedic disease in the month preceding the inclusion
- •surgery scheduled within 3 weeks after enrollment
- •surgery at upper limbs in the three months preceding the inclusion
- •pregnant or nursing women
结局指标
主要结局
Physical activity variables of upper limbs movement at home
时间窗: each day for 14 days
A watch containing and inertial system will be worn by non-ambulant patients with neuromuscular diseases at home for 14 days. Physical activity variables will be deduced from these measurements.
次要结局
- Physical activity variables of upper limbs movement in standardized setting(14 days after baseline)